Status:
WITHDRAWN
HDAC Inhibitor Augmentation to Clozapine
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
The main goal of this pilot study is to test the extent to which adjunctive treatment with the histone deacetylase (HDAC) inhibitor vorinostat improves brain plasticity and cognition in a pilot placeb...
Detailed Description
The goal of this study is to perform a pilot clinical study with a small sample of subjects to evaluate the safety and tolerability of vorinostat when combined with clozapine treatment in patients wit...
Eligibility Criteria
Inclusion
- Diagnosed with DSM-5 Schizophrenia
- Receiving stable dose pf clozapine (≥ 300 mg per day) for at least 6 months before entering the study
Exclusion
- Taking specific psychotropic medications (lamotrigine and valproic acid)
- Current or recent (12-months) substance use or induced disorder
- History of significant neurological or medical disorders
- Intellectual disability
- Known contraindications to the administration of vorinostat per product labeling
- Women currently pregnant, planning to become pregnant, or receiving hormone therapy and refusing any form of birth control
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03263533
Start Date
April 1 2017
End Date
February 1 2019
Last Update
October 15 2024
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